There are about 21062 clinical studies being (or have been) conducted in Italy. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
This study will evaluate the safety and the efficacy of the MLN-DEXAMETHASONE, MLN-DEXAMETHASONE-CYCLOPHOSPHAMIDE, or MLN- THALIDOMIDE-DEXAMETHASONE induction combinations, followed by MLN maintenance in newly diagnosed elderly Multiple Myeloma patients. 183 patients, males and females, older than 65 years old or younger but considered not eligible for high-dose chemotherapy and transplantation, enrolled in different sites, will take part in this study. The duration of the study is approximately 5 years.
1. To compare the efficacy and safety of pharmacokinetic (PK)-guided treatment with BAX 855 targeting FVIII trough levels of 1-3% and approximately 10% (8-12%) 2. To further characterize pharmacokinetic (PK) and pharmacodynamic (PD) parameters of BAX 855
This study seeks to confirm a demonstrated treatment effect of intepirdine (RVT-101) as an adjunctive therapy to donepezil for the treatment of subjects with Alzheimer's disease.
To evaluate the efficacy of subcutaneous (SC) evolocumab, compared to regularly scheduled low-density lipoprotein cholesterol (LDL-C) apheresis, on reducing the need for future apheresis.
Primary Objectives: - To demonstrate the superiority of alirocumab in comparison with placebo in the reduction of calculated low-density lipoprotein cholesterol (LDL-C) in participants with diabetes treated with insulin and with hypercholesterolemia at high cardiovascular risk not adequately controlled on maximally tolerated LDL-C lowering therapy. - To evaluate the safety and tolerability of alirocumab in participants with diabetes treated with insulin. Secondary Objective: To demonstrate that alirocumab was superior in comparison to placebo in its effects on other lipid parameters (i.e., measured LDL-C, non-high-density lipoprotein cholesterol [non-HDL-C], apolipoprotein B [Apo B], total cholesterol [TC], lipoprotein a [Lp(a)], high density lipoprotein cholesterol [HDL-C], triglyceride [TG] levels, triglyceride rich lipoproteins [TGRL], apolipoprotein A-1 [Apo A-1], apolipoprotein C-III [Apo C-III], and LDL particle number and size).
Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis: The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study (GLORIA)
Neonatal hypoglycemia is associated with brain injury and impaired neurodevelopment outcomes in very low birth weight infants (VLBWI). Glycemic monitoring is usually performed by capillary or central line sampling but does not identify up to 81% of hypoglycemic episodes in preterm newborns. The investigators aim to assess if a continuous glucose monitor (CGM) can be used to maintain euglycemia (defined as a target value 72-144mg/dl) in VLBWI. It will be enrolled newborns ≤32 weeks gestational age and/or of birthweight ≤1500 g, within 48 hours of life, they will be randomized in two study arms, both them will wear Dexcom G4 Platinum CGM: 1) Unblinded group (UB): glucose daily intake will be modulated according to CGM (Dexcom G4 Platinum) during the first 7 days of life, alarms for hypos/hyper will be active; 2) Blinded group (B), glucose infusion rate will be modified according to 2-3 daily capillary glucose tests, alarms for hypos will be switched off. Pain at insertion will be evaluated with the validated Premature Infant Pain Profile (PIPP) scale. The estimated numerosity is 50 patients (25 for each arm).
This is a retrospective observational study aimed at describing the characteristics and outcome of CLL patients included in the NPP in Italy in a period of time ranging from the start of the NPP until November, 30th 2014. A longitudinal survey will be carried out by collecting data of patients who received at least 1 dose of Ibrutinib. All patients will be observed for at least 12 months from the treatment start.
Surgery is the only effective treatment for morbid obesity and can be divided into restrictive surgeries (Lap Band and Sleeve gastrectomy), malabsorptive surgeries (Biliary pancreatic deviation and duodenal switch) or a combination of both (RYGBP). This later technique is the most common and most effective surgical procedure performed worldwide and has been processed to be an effective treatment of morbid obesity and its complications, achieving excess weight loss of 65 to 80 % ; 1-2 years after surgery (1,2). Vertical gastric plication is a novel surgical approach for reducing the stomach capacity. Anterior surface plication and greater curvature plication are variations of vertical gastric plication that reduce the gastric capacity through infolding of the anterior surface or greater curvature of the stomach, respectively. These approaches have been tested, with positive results (3,4). A transoral or endoluminal approach (ie, a procedure that requires no incision, because access is granted through the mouth) offers the potential for additional benefit to the patient, because the procedures continue to become more and more minimally invasive. Advances in endoluminal devices are now allowing clinicians the ability to begin exploring bariatric procedures performed via flexible endoscopy. Although these procedures may not be as effective as their surgical counterparts, these less-invasive options may relieve patients of the significant risks associated with surgery (5).
To evaluate the change in quality of life (NEI VFQ 25) in subjects with DME during the first year of treatment with aflibercept according to the EU Label.